BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 2132039 · Received June 16, 2011

    Report

    Report Number
    2183613-2011-00243
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    March 13, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): ANALYSIS COULD NOT DUPLICATE THE CUSTOMER COMMENTS. ANALYSIS DID FIND THAT THE UPPER AND LOWER CASES, BATTERY RELEASE AND RING COVER WERE CONTAMINATED, ONE SIDE BAIL COVER WAS BROKEN, THE RING BAIL WAS BENT, AND THE BATTERY DRAWER WAS BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS ASYNC PACING. FURTHER INFORMATION WAS RECEIVED THAT THE DEVICE WAS ON A PATIENT, AND IT DID NOT CAPTURE IN THE VOO MODE. THE DEVICE WAS CHANGED, AND THERE WERE NO PATIENT COMPLICATIONS. WHEN THE BIOMEDICAL ENGINEER CHECKED THE DEVICE, NO PROBLEMS WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5388 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention